Condition category
Mental and Behavioural Disorders
Date applied
10/12/2017
Date assigned
19/12/2017
Last edited
14/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Current plain English summary as of 14/01/2020:

Background and study aims
Posttraumatic stress disorder (PTSD) may develop after exposure to a traumatic event. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based psychological treatment for PTSD. It is yet unclear whether eye movements also reduce stress reactivity in
PTSD patients.
The aim of this study is to test whether eye movements, as provided during Eye Movement Desensitization (EMD), is more effective in reducing stress reactivity in PTSD patients, as compared to a retrieval-only control condition.

Who can participate?
Adults aged 18 and older who have fulfilling diagnostic criteria for posttraumatic stress disorder (PTSD).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group will receive EMD treatment. Those in the second group will receive a similar therapy but excluding the eye movements. After four to six sessions in each condition, stress reactivity will be measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, the post-intervention assessment will be conducted, including stress-reactivity and PTSD symptoms. Finally, at six months, a follow-up assessment is conducted to be able to evaluate the longer-term effectively.

What are the possible benefits and risks of participating?
There is a direct benefit for participation in this study. The participants will gain treatment to reduce their PTSD symptoms. This treatment will help their traumatic problem. Their participation will help us in better understanding of how effective EMD may be beneficial for
people who suffer from the traumatic event. Recalling traumatic memories may lead to uncomfortable feelings that will most likely quickly pass. However, if participants feel an uncomfortable feeling, there are techniques to reduce and calm their emotions. The therapist
will give stabilization techniques until they calm.

Where is the study run from?
The study runs from Vrije Universiteit Amsterdam (Netherlands) and takes place in Yayasan Pulih, a trauma center in Jakarta, the “psychology service Unisba” in Bandung and the “crisis center Unjani” in Cimahi. All of the cities are in Indonesia.

When is the study starting and how long is it expected to run for?
April 2018 to April 2020

Who is funding the study?
BUDI LN_LPDP (Indonesian Endowment Fund for Education) (Indonesia)

Who is the main contact?
1. Prof.dr.Anja C.Huizink (Scientific)
a.c.huizink@vu.nl
2. Dr. Marit Sijbrandij (Scientific)
e.m.sijbrandij@vu.nl
3. Prof. Wilis Srisayekti
wilis@unpad.ac.id

_____
Previous plain English summary:
Background and study aims
Eye Movement Desensitization and Reprocessing (EMDR) is one of the most effective therapy for Posttraumatic Stress Disorder (PTSD). EMDR is a therapy that uses eye movement to help patient’s process distressing memories and beliefs. However, part of the scientific community is skeptical about EMDR, especially whether eye movements or other laterally alternating stimuli play a role in the EMDR effect. It is necessary to provide evidence-based interventions to reduce PTSD-symptoms effectively and efficiently. These treatments are associated with decreases in avoidance, re-experiencing, negative cognitions, and mood-related symptoms. Interventions that not only reduce the PTSD behavioral symptoms but also tackle the underlying psychoneuroendocrine (the relationship of hormones and human behaviour) mechanisms may potentially offer long-term effectiveness. Psychoneuroendocrine mechanism that may play a role in PTSD includes physiological stress reactivity and neuroendocrine stress response. Comprehensive understanding of both behavioral PTSD symptoms and their association with psychophysiological parameters will contribute to the development of indicators of prognosis of treatment outcome and preventive interventions in high-risk groups. The aim of this study is to examine whether regular EMDR treatment is more effective than a similar treatment but without the eye movement components (retrieval only) in terms of reducing PTSD symptoms in PTSD patients. The goal is to investigate whether EMDR results in a more positive change in stress reactivity associated with PTSD symptom reduction as compared to the retrieval only.

Who can participate?
Adults aged 18 and older who attend in the mental health clinic with fulfilling diagnostic criteria for posttraumatic stress disorder (PTSD).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group will receive the EMDR treatment. Those in the second group will receive a similar therapy but excluding the eye movements. After four sessions in each condition, stress reactivity will be measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, the post-intervention assessment will be conducted, including stress-reactivity and PTSD symptoms. Finally, at six months, a follow-up assessment is conducted to be able to evaluate longer-term effectively.

What are the possible benefits and risks of participating?
There is a direct benefit for participation in this study. The participants will gain treatment to reduce their PTSD symptom. This treatment will help their traumatic problem. Their participating will help us in better understanding how effective EMDR may be beneficial for people who suffer from the traumatic event. Recalling traumatic memories may lead to uncomfortable feelings that will most likely quickly pass. However, if participants feel an uncomfortable feeling, there are techniques to reduce and calm their emotion. The therapist will give stabilization technique until they calm.

Where is the study run from?
The study run from Vrije Universiteit Amsterdam (Netherlands) and takes place in Yayasan Pulih, trauma centre in Jakarta, Indonesia.

When is the study starting and how long is it expected to run for?
February 2017 to October 2019 (updated 21/05/2019, previously: May 2019)

Who is funding the study?
BUDI LN_LPDP (Indonesian Endowment Fund for Education) (Indonesia)

Who is the main contact?
1. Prof.dr.Anja C.Huizink (Scientific)
a.c.huizink@vu.nl
2. Dr. Marit Sijbrandij (Scientific)
e.m.sijbrandij@vu.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Eka Susanty

ORCID ID

Contact details

Vrije Universiteit Amsterdam
Faculty of Behavioural and Movement Sciences
Clinical
Neuro and Developmental Departement
Van der Boechorststraat 1
Amsterdam
1183 DE
Netherlands
+31 20 59 88888
eka.susanty@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ID_01

Study information

Scientific title

A comparison of Eye Movement Desensitization and Reprocessing (EMDR) and Retrieval only Condition for Posttraumatic Stress Symptoms on Physiological Markers: A Randomized Controlled Trial

Acronym

Study hypothesis

Current study hypothesis as of 14/01/2020:
Patients with PTSD receiving the EMD condition will show larger reductions in stress reactivity in
response to trauma scripts and stronger improvements in neurocognitive functioning than the
retrieval-only control group.
_____
Previous study hypothesis:
1. Psychophysiological parameters of PTSD participants show more positive alterations in the EMDR condition as compared to the retrieval only condition
2. Psychophysiological parameters of PTSD participants show a more positive change in stress reactivity associated with PTSD symptom reduction in the EMDR condition as compared to the retrieval only condition.

Sub-hypothesis :
2.1 Heart Rate level is lower in participants in the EMDR condition
2.2 Cortisol Daily output shows a more normal pattern in the EMDR condition

Ethics approval

The Research Ethics Committee Universitas Padjadjaran Bandung, 26/06/2018, 655/UN6.KEP/EC/2018

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Posttraumatic stress disorder

Intervention

Current interventions as of 14/01/2020:
In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre-intervention (T0) is conducted before he or she are randomised and introduced to the corresponding study arm (study arm 1 and 2). Participants are randomised to one of two groups. This study compares the EMDR condition with an exposure condition, which consists of a similar therapy protocol but excluding the eye movements.

The time span between T0 and the first intervention session are kept to about one to two weeks. After four sessions in each condition, stress reactivity is measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, post-intervention assessment are conducted (T2), including stress-reactivity, brain activity and PTSD symptoms. Finally, at six months (T3) a follow-up assessment is conducted to be able to evaluate longer-term effectivity. The follow-up assessment are performed in two steps. First, participants are contacted personally and motivated to complete the follow-up instrument. In case participants refuse the telephone interview, they are offered an assessment of the primary outcome only. If participants still refuse, they are asked to provide reasons for their refusal, which is documented.

The endpoints of the study change in neurobiological parameters; Heart rate (HR), Heart Rate Variability (HRV) and Pre-ejection (PEP) responses to trauma-related stimuli. Secondary outcomes of the study are change of cortisol level and reduction in PTSD symptoms based on Clinician-Administered PTSD Scale (CAPS-5), and PCL-5 (PTSD Checklist for DSM-5). CAPS-5 is a structured interview designed to examine the major symptoms of Post-Traumatic Stress Disorder. It consists of item PTSD symptom questions corresponding to DSM-5 diagnosis for PTSD. PCL-5 consists 20 items that assess the 20 DSM 5 symptom of PTSD.

EMD treatment protocol
The procedures of EMD intervention will be carried out in line with the standard EMDR protocol (Shapiro & Maxfield, 2002). Since we aimed to evaluate the effects of eye movement during retrieval of a traumatic memory, we decided to omit the installation phase from the original
EMDR procedure in both study groups. It has been suggested that the installation phase may be counter-effective, since performing eye movements when retrieving a positive cognition or image (as done in the installation phase), may render that positive image less vivid and positive (van den Hout & Engelhard, 2012). EMD will be given during 4 to a maximum of 6 sessions, and each session lasts 45 -60 minutes. The therapist will provide at least 4 sessions and stop when the Subjective Units Distress (SUDs) scales = 0 or 1 for all target memories. SUDs are measure the level of distress before and after target memory processing, where 0 is no disturbance or neutral and 10 is the highest disturbance.
EMD consists of the following steps: 1) Client History and treatment planning: obtaining information regarding the clients’ clinical condition, including intrusive emotions and physical sensations. 2) Preparation: building a therapeutic bond with the client, the explanation of EMDR
process and its effects. 3) Assessment: identification of the target visual image of the traumatic memory and associated negative emotions. The participant describes the intensity of the negative emotions on a 0-10 SUDs scale). 4) Desensitization: clients will be asked to focus on
target traumatic events, while focusing their eyes on the therapist’s finger that moves from left to right an back in the participant’s visual field. The therapist will conduct EM for 24 cycles several times. This phase will end if SUD scores reach 0 or 1. Next, participants will scan their body until any tension disappears.5) Closure: the session is closed, and the stabilization techniques and relaxation exercises are reviewed. Sessions 2-4 will start with a reevaluation of the patient’s progress and SUD scores of target events to guide the choice of continuing with the target traumatic event or choosing a new event.
The EMD treatments will be performed by experienced psychotherapists with at least one year of experience in treating PTSD patients. Eight therapists are planned to be recruited through colleagues from the Clinical Psychologist Association (IPK). Therapists will be weekly supervised by an accredited EMDR supervisor.

Retrieval only condition (control)
Control participants will receive the same treatment as the participants in the EMD group, except that during phase 4) Desensitization, no eye movements will be performed during retrieval of the trauma memory.

_____
Previous interventions 14/01/2020:
In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre-intervention (T0) is conducted before he or she are randomised and introduced to the corresponding study arm (study arm 1 and 2). Participants are randomised to one of two groups. This study compares the EMDR condition with an exposure condition, which consists of a similar therapy protocol but excluding the eye movements.

The time span between T0 and the first intervention session are kept to about one to two weeks. After four sessions in each condition, stress reactivity is measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, post-intervention assessment are conducted (T2), including stress-reactivity, brain activity and PTSD symptoms. Finally, at six months (T3) a follow-up assessment is conducted to be able to evaluate longer-term effectivity. The follow-up assessment are performed in two steps. First, participants are contacted personally and motivated to complete the follow-up instrument. In case participants refuse the telephone interview, they are offered an assessment of the primary outcome only. If participants still refuse, they are asked to provide reasons for their refusal, which is documented.

EMDR therapy is given in six sessions, each session lasts 45-60 minutes. The standard procedure of EMDR are followed: Client history and treatment planning, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. In session 1, all procedures steps are conducted and in the others sessions (session 2 to 7), the therapy can be given from the second stage (preparation) and continued to stage 7 (closure) following reevaluation stage, to see the progress of the individual. In the control group, there is no eye movement during exposure of desensitization and installation phases while all the other components of the treatment protocol are kept the same. This tests whether the addition of Eye Movements is necessary to result in better treatment outcomes on both a behavioral level and on a psychoneuroendocrine level.

The endpoints of the study change in neurobiological parameters; Heart rate (HR), Heart Rate Variability (HRV) and Pre-ejection (PEP) responses to trauma-related stimuli. Secondary outcomes of the study are change of cortisol level and reduction in PTSD symptoms based on Clinician-Administered PTSD Scale (CAPS-5), and PCL-5 (PTSD Checklist for DSM-5). CAPS-5 is a structured interview designed to examine the major symptoms of Post-Traumatic Stress Disorder. It consists of item PTSD symptom questions corresponding to DSM-5 diagnosis for PTSD. PCL-5 consists 20 items that assess the 20 DSM 5 symptom of PTSD.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 14/01/2020:
Heart Rate Variability (HRV) measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3)
_____
Previous primary outcome measure:
1. Heart Rate (HR)/Heart Rate Variability (HRV) is measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3)
2. Pre-ejection period (PEP) is measured using the VU AMS device at baseline (T1), during intervention (T1), post-treatment (T2) and 6 months follow up (T3)

Secondary outcome measures

Current secondary outcome measures as of 14/01/2020:
At baseline (T0), during intervention (T1), post-treatment (T2) and 6 months follow up (T3):
1. Heart Rate (HR) measured using the VU AMS device
2. Pre-ejection period (PEP) measured using the VU AMS device
3. Diagnosis of DSM-5 Axis I disorder using the SCID-5 questionnaire
4. PTSD symptoms using the PCL-5
5. Experiences of traumatic events using Live Events Checklist (LEC)
6. Anxiety and depression symptoms using The Hopkins Symptoms Checklist-25 (HSCL-25)
7. Perceived feelings and thought of stress during the last month using The Perceived Stress Scale (PSS)
8. Quality of life using the Indonesian version of the World Health Organization Quality of Life (WHOQOL-BREF)
9. Neurocognitive Functioning using the Digit Span subtest of the Indonesian WAIS-IV
10. Encoding, short-term retrieval, and recognition of verbal information using The California Verbal Learning Test (CVLT)
11. Information processing speed, shift of attention, planning, and cognitive flexibility using The Trail Making Test (TMT)

_____
Previous secondary outcome measures:
1. Cortisol level is measured using salivary samples using The Salimetrics Cortisol Enzyme Immunoassay Kit at baseline (T0), post-treatment (T2) and six months follow up (T3)
2. PTSD symptom score is measured using CAPS (Clinican Administered PTSD Scale) at baseline (T0), post-treatment (T2) and 6 months follow up (T3)
3. PTSD symptom score is measured using PTSD Checklist for DSM-5 at baseline (T0), post-treatment (T2) and six months follow up (T3)

Overall trial start date

02/02/2017

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 14/01/2020:
1. Diagnostic and Statistical Manual of Mental Disorder, fifth edition (DSM-5) diagnosis of PTSD as diagnosed with the Structured Clinical Interview for DSM-5 disorders (SCID-5)
2. Age of 18 years or older

______
Previous inclusion criteria:
1. Individuals who were either diagnosed posttraumatic stress disorder (PTSD) by a professional, i.e., by a clinical psychologist and meet DSM-V-TR, the diagnostic rule which requires at least one criteria of A, B, and C and at least two criteria of D and E and with cut off 33 of PCL-5 score
2. Suffering from posttraumatic stress symptoms on a subclinical level with one symptom in each criterion of PTSD symptoms and with cut off 20 of PCL-5 score
3. Minimal age of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We expect to detect a difference between the EMD condition and the exposure condition of a medium effect size (cohen’s d = 0.04). Based on this assumption, we need a total sample size of n=70

Total final enrolment

88

Participant exclusion criteria

Current inclusion criteria as of 14/01/2020:
1. Current or previous psychotic disorder
2. Current substance use disorder
3. Acute suicidality
4. Current organic disorder i.e. epileptic, brain damage

_____
Previous exclusion criteria:
1. Individuals with current organic disorders, psychotic disorders, substance abuse, or suicidal ideation will be excluded
2. Individuals that are currently taking any medication for psychological or psychiatric disorders are excluded

Recruitment start date

01/04/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Indonesia

Trial participating centre

Yayasan Pulih (The Lead Centre)
Jl Teluk Peleng No,63 RT 5/ RW8 Pasar Minggu Jakarta Selatan
Jakarta
12520
Indonesia

Trial participating centre

Universitas Islam Bandung (UNISBA)
Lab Psikologi Pasca sarjana UNISBA Jl Purnawarman no 59
Jawa Barat
40117
Indonesia

Trial participating centre

Universitas Jenderal Achamad Yani (UNJANI)
Laboratorium Fakultas Psikologi Unjani Jl Terusan Jenderal Sudirman
Cimahi
40521
Indonesia

Sponsor information

Organisation

BUDI LN_LPDP (Indonesian Scholarship)

Sponsor details

A.A Maramis II Building 2nd floor
Jl Lapangan Banteng Timur no 1
Jakarta
10710
Indonesia

Sponsor type

Government

Website

www.lpdp.kemenkeu.go.id

Funders

Funder type

Not defined

Funder name

Indonesia Endowment Fund for Education (LPDP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Eka Susanty (e.s.susanty@vu.nl).

Intention to publish date

30/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/01/2020: The following changes were made to the trial record: 1. The study hypothesis was changed. 2. The overall end date was changed from 30/05/2020 to 30/04/2020. 3. The interventions were changed. 4. The primary outcome measure was changed. 5. The secondary outcome measures were changed. 6. The inclusion criteria were changed. 7. The exclusion criteria were changed. 8. The recruitment start date was changed from 30/11/2018 to 01/04/2018. 9. The trial participating centres "Klinik Utama Azzalea (Yayasan Jari)" and "Trauma centre of Refugee Survivors of the Agung’s volcano disaster" were removed. 10. The trial participating centres "Universitas Islam Bandung (UNISBA)" and "Universitas Jenderal Achamad Yani (UNJANI)" were added. 11. The plain English summary was updated. 12. The total final enrolment was added. 11/12/2019: The following changes have been made: 1. The recruitment end date has been changed from 15/11/2019 to 31/12/2019. 2. The overall trial end date has been changed from 30/04/2020 to 30/05/2020. 18/11/2019: The recruitment end date was changed from 30/10/2019 to 15/11/2019. 04/07/2019: Internal review. 21/05/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/04/2019 to 30/10/2019. 2. The overall end date was changed from 31/10/2019 to 30/04/2020. 3. The intention to publish date was changed from 31/10/2020 to 30/04/2021. 4. The plain English summary was updated to reflect these changes. 23/10/2018: The following changes were made: 1. The recruitment start date was updated from 01/08/2018 to 30/11/2018. 2. The recruitment end date was updated from 31/08/2018 to 30/04/2019. 3. The overall trial end date was updated from 30/07/2019 to 31/10/2019. 4. The intention to publish date was updated from 01/07/2020 to 31/10/2020. 30/07/2018: The ethics approval has been updated. 17/07/2018: The following changes have been made to the trial record: 1. The recruitment start date has been changed from 01/04/2018 to 01/08/2018 2. The recruitment end date has been changed from 30/06/2018 to 31/08/2018 3. The overall trial end date has been changed from 30/05/2019 to 30/07/2019 4. The intention to publish date has been changed from 01/12/2019 to 01/07/2020